P5009The major bleeding event is the stronger predictor of long term mortality rather than the coronary event in the secondary prevention of ischemic heart disease in Japan

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Kageyama

Abstract Background/Introduction Secondary prevention for ischemic heart disease (IHD) is important part in health care. To improve the risk factor control with general practitioners, we decided to set up a unique referral system to connect the hospital and outpatient clinics. Purpose Long term prognosis of IHD patients is unknown. The aims of this study are introducing our unique audit referral system and showing the long term prognosis of IHD patients with optimal second prevention therapy. Methods IHD patient registry was established in 2009 to connect cardiologists in the core hospitals and more than 200 general practitioners in Shizuoka city. To audit the treatment of general practitioners, we adopted a circulation type cooperative form. Target values of risk factors are as follows; low-density-lipoprotein cholesterol (LDL-C) concentration less than 100 mg/dl, HbA1c in diabetic patients less than 7%, systolic blood pressure (SBP) less than 130mmHg, and diastolic blood pressure (DBP) less than 80mmHg. General practitioners are required to introduce registered patients at least once a year even there is no event. Mean follow-up interval was 2001±794 days. Results We could follow 1240 patients who were registered from May 2009 to December 2013 and followed by at least one visit to the hospital in the prescribed manner until September 2018. Mean age was 77.3±10.6 years old, and 39.6% of them had old myocardial infarction. Latest risk factor controls are as follows; LDL-C 88.0±21.3mg/dl, HbA1c control in diabetic patients 7.0±1.1%, SBP and DBP 133.7±16.5 and 75.0±11.8mmHg respectively. Cumulative incidence of all-cause death was 10.8%, cardiac death was 1.5%, and coronary event (combination of cardiac death, myocardial infarction, angina pectoris which need hospitalization, and any lesion revascularization) was 15.8%. Cumulative incidence of major bleeding was 2.6%. The patients were divided into three groups without overlapping; major bleeding group (n=34), coronary event group (n=195), and event-free group (n=1049). The nonparametric test showed significant differences between three groups concerning age (p=0.026), the rate of using antithrombotic drugs (p<0.001) and mortality (p=0.017). Kaplan-Meier method concerning all-cause death showed a significant difference between event-free group and major bleeding group (log rank p=0.002), and coronary event group and major bleeding group (p=0.026), while no statistical difference between event-free group and coronary event group. Cumulative survival rate Conclusions Our unique referral system revealed long term events in the stable IHD patients in Japan. The major bleeding event is a strong predictor of long term mortality in IHD patients rather than the coronary event.

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Alpesh Amin ◽  
Allison Keshishian ◽  
Lin Xie ◽  
Onur Baser ◽  
Kwanza Price ◽  
...  

Objective: The study aim was to compare major bleeding risk and health care costs after initiating oral anticoagulants (OACs) for treatment-naïve non-valvular atrial fibrillation (NVAF) patients. Methods: Patients in the Medicare advantage population prescribed apixaban, rivaroxaban, dabigatran or warfarin were selected from the Optum Research Database 01JAN2013-31DEC2014. The first OAC prescription date was designated as the index date. Patients were required to have a NVAF diagnosis, continuous health plan enrollment for 6 months and no OAC claims before the index date. Patients were classified into four cohorts based on their index OAC prescription. Major bleeding events, identified by the Cunningham algorithm plus additional bleeding sites, were compared using a Cox proportional hazards model. Health care costs were calculated per patient per month and compared using generalized linear models. Results: The study included 36,260 patients: 3,762 apixaban, 2,677 dabigatran, 8,740 rivaroxaban, and 21,081 warfarin patients. CHA2DS2-VASc score was higher in apixaban patients (4.2) compared to dabigatran and rivaroxaban (both 4.0; p<0.001), but lower than in warfarin patients (4.3; p<0.001). After adjusting for baseline characteristics, apixaban patients were significantly less likely to have a major-bleeding event within one year of treatment initiation compared to rivaroxaban (HR=0.69; 95% CI=0.59-0.81) and warfarin (HR=0.71; 95% CI=0.61-0.82) patients and trended towards numerically lower major bleeding compared to dabigatran patients (HR=0.87; 95% CI=0.72-1.06). Major bleeding-related medical costs were lower in apixaban patients ($53) compared to rivaroxaban ($111) and warfarin ($138) patients (p<0.001) and similar to dabigatran patients ($44, p=0.370). Furthermore, apixaban patients incurred lower all-cause medical costs ($1,646) compared to dabigatran ($1,974, p=0.02), rivaroxaban ($1,909, p=0.002) and warfarin ($2,162, p<0.001) patients. Conclusion: In a large national Medicare advantage population, treatment-naïve NVAF patients treated with apixaban were significantly less likely to have a major-bleeding event compared to those prescribed rivaroxaban or warfarin and had significantly lower medical costs.


Author(s):  
Hisashi Ogawa ◽  
Yoshimori An ◽  
Kenjiro Ishigami ◽  
Syuhei Ikeda ◽  
Kosuke Doi ◽  
...  

Abstract Aims Oral anticoagulants reduce the risk of ischaemic stroke but may increase the risk of major bleeding in atrial fibrillation (AF) patients. Little is known about the clinical outcomes of patients after a major bleeding event. This study assessed the outcomes of AF patients after major bleeding. Methods and results The Fushimi AF Registry is a community-based prospective survey of the AF patients in Fushimi-ku, Kyoto, Japan. Analyses were performed on 4304 AF patients registered by 81 institutions participating in the Fushimi AF Registry. We investigated the demographics and outcomes of AF patients who experienced major bleeding during follow-up period. During the median follow-up of 1307 days, major bleeding occurred in 297 patients (6.9%). Patients with major bleeding were older than those without (75.6 vs. 73.4 years; P &lt; 0.01). They were more likely to have pre-existing heart failure (33.7% vs. 26.7%; P &lt; 0.01), history of major bleeding (7.7% vs. 4.0%; P &lt; 0.01), and higher mean HAS-BLED score (2.05 vs.1.73; P &lt; 0.01). On landmark analysis, ischaemic stroke or systemic embolism occurred in 17 patients (3.6/100 person-years) after major bleeding and 227 patients (1.7/100 person-years) without major bleeding, with an adjusted hazard ratio (HR) of 1.93 [95% confidence interval (CI), 1.06–3.23; P = 0.03]. All-cause mortality occurred in 97 patients with major bleeding (20.0/100 person-years) and 709 (5.1/100 person-years) patients without major bleeding [HR 2.73 (95% CI, 2.16–3.41; P &lt; 0.01)]. Conclusion In this community-based cohort, major bleeding is associated with increased risk of subsequent all-cause mortality and thromboembolism in the long-term amongst AF patients. Trial registration https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000005834. (last accessed 22 October 2020)


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K Ishigami ◽  
Y Aono ◽  
S Ikeda ◽  
K Doi ◽  
Y An ◽  
...  

Abstract Background Thrombocytopenia is sometimes found in routine blood tests and is reported as a risk factor of major bleeding events and incidence of all-cause death after percutaneous coronary intervention. However, the influence of thrombocytopenia on clinical outcomes in patients with atrial fibrillation (AF) remains unknown. Purpose We aimed to investigate relationship between baseline platelet count and clinical outcomes such as all-cause death, hospitalization for heart failure, and the major bleeding event in AF patients. Methods The Fushimi AF Registry was designed to enroll all of the AF patients in Fushimi-ku, Kyoto. Fushimi-ku is densely populated with a total population of 283,000 and is assumed to represent a typical urban community in Japan. Follow-up data with baseline platelet counts were available in 4,179 patients from March 2011 to November 2018. We divided the entire cohort into 3 groups according to baseline platelet level: No thrombocytopenia (≥150,000/μL, n=3,323), Mild thrombocytopenia (100,000–149,999/μL, n=707), and Moderate/severe thrombocytopenia (≤99,999/μL, n=149). Results In the entire cohort, the mean age was 73 years, 40% were women, and the mean body weight and body mass index was 59 kg and 23.1 kg/m2, and the median platelet count were 192,000/μL (interquartile range 156,000 to 232,000/μL), respectively. Compared to No thrombocytopenia, patients with thrombocytopenia were older (No vs. Mild vs. Moderate/severe; 73.3 years vs. 76.5 years vs. 75.8 years, p<0.0001), more likely to have heart failure (27.0% vs. 32.8% vs. 41.6%, p<0.0001), more likely to have chronic renal disease (35.7% vs. 42.6% vs. 57.7%, p<0.0001), and had higher CHADS2 score (2.05 vs. 2.17 vs. 2.34, p=0.0039) and CHA2DS2-VASc score (3.40 vs. 3.52 vs. 3.71, p=0.0416). Patients with thrombocytopenia had lower hemoglobin (13.0 vs. 12.8 vs. 11.6, p<0.0001) than No thrombocytopenia. However, prevalence of previous major bleeding events was comparable between three groups (4.66% vs. 4.67% vs. 5.37%, p=0.92) On Kaplan-Meier analysis, the incidence of all-cause death was higher in Mild group (hazard ratio [HR] 1.51; 95% confidence interval [CI] 1.28–1.77) and Moderate/severe group (HR 2.97; 95% CI 2.28–3.80) than No group (Figure 1). The incidence of hospitalization for heart failure was higher in Mild group (HR 1.62; 95% CI 1.31–1.99) and Moderate/severe group (HR 2.64; 95% CI 1.76–3.81) than No group (Figure 2). The incidence of major bleeding event was higher in Mild group (HR 1.46; 95% CI 1.11–1.91) and Moderate/severe group (HR 2.45; 95% CI 1.41–3.91) than No group (Figure 3). Conclusion Thrombocytopenia in AF patients was associated with higher incidence of all-cause death, hospitalization for heart failure, and major bleeding event in the Fushimi AF Registry. Acknowledgement/Funding Pfizer, Bristol-Myers Squibb, Boehringer Ingelheim, Bayer Healthcare,and Daiichi-Sankyo


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Zhubin Lun ◽  
Li Lei ◽  
Dianhua Zhou ◽  
Ming Ying ◽  
Liwei Liu ◽  
...  

Abstract Background The definitions of contrast-associated acute kidney injury (CA-AKI) are diverse and have different predictive effects for prognosis, which are adverse for clinical practice. Few articles have discussed the relationship between these definitions and long-term prognosis in patients with diabetes. Methods A total of 1154 diabetic patients who were undergoing coronary angiography (CAG) were included in this study. Two definitions of CA-AKI were used: CA-AKIA was defined as an increase ≥ 0.3 mg/dl or > 50% in serum creatinine (SCr) from baseline within 72 h after CAG, and CA-AKIB was defined as an increase ≥ 0.5 mg/dl or > 25% in SCr from baseline within 72 h after CAG. We used Cox regression to evaluate the association of these two CA-AKI definitions with long-term mortality and calculate the population attributable risks (PARs) of different definitions for long-term prognosis. Results During the median follow-up period of 7.4 (6.2–8.2) years, the overall long-term mortality was 18.84%, and the long-term mortality in patients with CA-AKI according to both CA-AKIA and CA-AKIB criteria were 36.73% and 28.86%, respectively. We found that CA-AKIA (HR: 2.349, 95% CI 1.570–3.517, p = 0.001) and CA-AKIB (HR: 1.608, 95% CI 1.106–2.339, p = 0.013) were associated with long-term mortality. The PARs were the highest for CA-AKIA (31.14%), followed by CA-AKIB (14.93%). Conclusions CA-AKI is a common complication in diabetic patients receiving CAG. The two CA-AKI definitions are significantly associated with a poor long-term prognosis, and CA-AKIA, with the highest PAR, needs more clinical attention.


2021 ◽  
Vol 9 (4) ◽  
pp. 511-520
Author(s):  
Z. Wang ◽  
E. A. Asaphyeva ◽  
T. I. Makeeva

Abstract. Recently, quantitative analysis of the level of the N-terminal prohormone of the brain naturetic peptide (NT-proBNP) has been widely used to diagnose heart failure (HF). A statistically significant correlation was found between the serum NT-proBNP concentration and HF stage. It was found that in patients with high cardiovascular risk, NT-proBNP has the highest predictive value in relation to mortality. In young and middle-aged patients with diabetes mellitus (DM) with myocardial infarction (MI) and stents of an infarct-associated artery, the frequency of unfavorable remodeling (UR) of the left ventricle (LV) in the long-term prognosis was studied. The frequency of atherosclerotic lesions of the coronary arteries (CA) in patients with diabetes in acute coronary syndrome (ACS) was determined, the results of echocardiographic parameters were presented in the follow-up dynamics, the value of serum NT-proBNP in predicting LV UR 12 months after myocardial infarction (MI) was determined.Aim of study. To assess the diagnostic capabilities of NT-proBNP in the long-term prediction of the development of LV infarction in patients with MI with diabetes in young and middle age after percutaneous coronary intervention (PCI).Design. Prospective controlled non-randomized trial. The patients were examined twice: on the first day of ACS after PCI with stenting of infarct-associated coronary artery and 12 months after AMI. The study included 191 patients with ACS with / without ST-segment elevation, who were divided into two groups. The main group included 76 patients with ACS with diabetes mellitus, the comparison group included 115 patients with ACS without diabetes mellitus. Patients in both groups were comparable in age, gender, comorbidity, and complications of AMI. The duration of diabetes was, on average, 6 years (from one to 12 years).Material and methods. All patients underwent electrocardiography, echocardiography, tests for the content of troponin I, NT-proBNP, glycosylated hemoglobin, lipids, determined the level of creatinine in the blood and the glomerular filtration rate according to the Modification of diet in renal disease (MDRD). All patients were examined twice: on the first day of ACS after PCI with stenting of infarct-associated coronary artery and 12 months later.Results. In 69% of diabetic patients with anterior myocardial infarction and in 63% of patients with posterolateral MI 12 months after PCI, signs of LV inferiority were revealed in the form of an increase in the indices of end-diastolic and systolic volumes of the LV and low ejection fraction (≤45%). In patients without diabetes, these figures were 18% and 31%, respectively. High concentrations of NT-proBNP on the first day of myocardial infarction after PCI were of the greatest value in the diagnosis and prognosis of LV UR after 12 months.Conclusion. The NT-proBNP level of more than 776 pg/ml on the first day after PCI is an indicator of an unfavorable long-term prognosis in patients with young and middle-aged diabetes in terms of the development of LV systolic dysfunction.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Miura ◽  
T Shimada ◽  
M Ohya ◽  
R Murai ◽  
H Amano ◽  
...  

Abstract Background Recently, the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria has been suggested as the standard definition of HBR. Purpose We aimed to investigate the risk stratification based on ARC-HBR Criteria for long-term bleeding event after everolimus-eluting stent implantation Methods The study population comprised 1193 patients treated with EES without in-hospital event between 2010 and 2011. Individual ARC-HBR criteria was retrospectively assessed. Major bleeding were defined as the occurrence of a Bleeding Academic Research Consortium type 3 or 5 bleeding event. The mean follow-up period was 2996±433 days. Results There were 656 patients (55.0%) in HBR-groups. Cumulative incidence of major bleeding was significantly higher in HBR-group (8.1% vs 3.4% at 4 year, and 16.2% vs 5.7% at 8 year, P&lt;0.001). Cumulative rate of major bleeding tend to be higher as the number of ARC-HBR criteria increased (≥2 Majors: 24.3%, 1 Major: 17.0%, ≥2 Minors:11.7%, and Non-HBR: 5.7%, P&lt;0.001). Conclusion ARC-HBR criteria successfully stratified the long-term bleeding risk after drug-eluting stent implantation in real-world practice. Funding Acknowledgement Type of funding source: None


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Takuro Abe ◽  
Kentaro Jujo ◽  
Takehiro Hata ◽  
KAZUHO KAMISHIMA ◽  
Hiroshi Koganei ◽  
...  

Introduction: The combination of aspirin and P2Y12 receptor antagonist is the standard antiplatelet therapy after percutaneous coronary intervention (PCI). Previous trials reported that prasugrel reduced the risk of ischemic events, but increased bleeding events compared to clopidogrel. Hypothesis: The prognostic impact of low-dose prasugrel (3.75 mg/day), which the dose was determined by phase II trial, is different from that of clopidogrel, depending on patient’s bleeding risk. Methods: This study is a subanalysis from the TWINCRE registry that is a multicentral prospective cohort including patients who underwent PCI. We analyzed 1,001 patients who received the combination of aspirin and prasugrel or clopidogrel after PCI. The primary endpoint was a composite of major bleeding event and major adverse cardiovascular and cerebrovascular events (MACCE) including any death, acute coronary syndrome, stent thrombosis, stroke and heart failure hospitalization. Results: There were 490 patients with high bleeding risk (HBR) and 511 patients with low bleeding risk (LBR), based on ARC-HBR criteria. In HBR patients, the Low-dose prasugrel group had significantly lower rates of MACCE (Log-rank, p=0.003) and the composite endpoint than the Clopidogrel group (p=0.001). While, in LBR patients, there was no significant difference in rates of MACCE or the composite endpoint between the groups (p=0.76, p=0.15, respectively), and a higher rate of major bleeding event in the Low-dose prasugrel group (p=0.002). With Cox proportional hazards analysis, low-dose prasugrel has still retained the superiority to clopidogrel regarding with the composite endpoint in HBR patients, even after adjusting with diverse covariates (hazard ratio: 0.33, 95% confidence interval: 0.16-0.65). Conclusion: In the multicenter cohort study in Japan, low-dose prasugrel showed a long-term prognostic superiority to clopidogrel only in HBR patients undergoing contemporary PCI.


Diabetes Care ◽  
2009 ◽  
Vol 32 (5) ◽  
pp. 822-827 ◽  
Author(s):  
E. Faglia ◽  
G. Clerici ◽  
J. Clerissi ◽  
L. Gabrielli ◽  
S. Losa ◽  
...  

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